The present invention relates to a percutaneous entry system, and more particularly, to an insertion system for bloodless percutaneous entry into a body vessel.
In the 1960's and 1970's percutaneous entry procedures for accessing body vessels were gaining increased importance in the medical field. During that time period, exposure of the clinician to blood during such percutaneous entry procedures was normally not a major concern. In the typical percutaneous entry procedure, the clinician would insert a needle through the skin and into a body vessel, such as an artery. When a “squirt” of blood shot out of the needle hub, the clinician received visual proof that the needle tip was in the correct location. A wire guide would then be inserted into the needle and passed into the artery. If a curved, or J-tipped, wire guide was used, a straightener or J-wire inserter was first placed in the needle hub. The wire guide was then passed through the inserter into the needle. With this arrangement the wire guide occluded the needle fairly well. However some blood was still able to seep out through the needle around the wire guide. Following insertion of the wire guide, the needle was removed, and the catheter or introducer sheath was advanced over the wire and into the artery.
At the time that these procedures were in common usage, seepage of a small amount of blood was considered acceptable. However, in later years, blood borne pathogens, such as hepatitis and HIV, became a major concern in the health care environment. Applicable regulations now mandate that health care providers utilize medical devices that eliminate or reduce the risk of exposure to blood whenever a suitable safety device is available.
Several commercial devices have been introduced to limit the exposure to blood during a medical procedure. Currently available products to control the escape of blood into the field of entry are generally aimed at controlling the first “squirt” of blood that passes through the needle when the needle is inserted into the artery. Two such devices are marketed commercially by AngioDynamics, Inc., of Queensbury, N.Y., namely the Sos Bloodless Entry Needle and the Pulse-Vu Needle. These devices have hemostatic valves on the needle hub to prevent the escape of the squirt of blood from the needle. A side arm extension tube attaches to a small chamber to collect the blood squirt, thereby providing visual confirmation that the tip of the needle is in the artery. However, when the clinician desires to insert additional apparatus through the hemostatic valve, such as a wire guide curve straightener or inserter, blood is free to pass through the apparatus and out into the field of entry. Blood may continue to leak out through the apparatus until such time as the wire is well into the artery and the apparatus is removed.
It would be desirable to provide a percutaneous insertion system that is substantially bloodless during not only the initial entry of the needle into the artery or vein, but also during the subsequent insertion of other apparatus, such as a wire guide straightener or a dilator.